Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.
Bio-Thera has added India to its BAT2506 partnership with Intas, granting exclusive commercialization rights and expanding a global network spanning the US and Canada, as the firm builds its presence in the emerging golimumab biosimilars market.
More than a dozen semaglutide generics hit the Indian market at sharp discounts post LOE for Novo Nordisk’s GLP-1 RA molecule, setting the stage for a high-octane battle in the diabetes and obesity segment. Can Novo hold steady amid the avalanche and what are KOLs looking for?
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
Henlius is advancing its nivolumab biosimilar HLX18 into Chinese trials, as it expands a global oncology pipeline. In 2025, the firm’s strong revenue growth was offset by rising R&D investment amid increasing contributions from overseas partnerships.
Natco has announced a 90% difference in the price of its semaglutide generic in multi-dose vials versus originator Novo Nordisk’s Ozempic pen ahead of launch tomorrow, as Novo’s patents on the product expire today. Its pen will be 70% cheaper.
Amid “significant uncertainty” for the off-patent industry caused by the war in Iran, the IGBA has warned that a prolonged conflict “could make solvent supply a critical concern” while escalating costs and squeezed margins could affect the long-term sustainability of affordable medicines.
Formycon expects its aflibercept biosimilar to enter European markets from the end of spring, as commercial paths also open up in Latin America and Asia Pacific countries.
Zydus’s investment in a differentiated drug-device combination for semaglutide has led to a win-win GLP-1 co-marketing deal with Lupin, even as the Indian drug regulator keeps a watch on advertising activities.
After creating a new biosimilars unit, Sandoz is now divesting its generics portfolio in Sub-Saharan Africa to the Strides Pharma group. Strides will acquire or license these brands for an initial $12m plus royalty, placing it among the top five firms in the region.
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
Samsung Bioepis’ explorations for an alternate semaglutide formulation will be powered by G2GBIO’s microsphere technology.
As Stada awaits the imminent closure of a deal that will see it come under the ownership of CapVest, the firm has reported 2025 sales that grew by 6% to €4.3bn, boosted by a double-digit biosimilars increase that drove Specialty sales above €1bn for the first time.
A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Merck, Johnson & Johnson, AstraZeneca and Roche are among the big pharma manufacturers that will face substantial exclusivity losses in the US this year.
Celltrion has added a subcutaneous formulation to its Avtozma biosimilar in the US, completing a dual-presentation strategy aimed at matching Actemra and improving uptake in a market where biosimilar penetration has so far remained limited.
Sandoz has struck a new deal with Samsung Bioepis covering up to five early-stage biosimilars, expanding an existing alliance as the Swiss-based firm ramps up investment, reorganizes its business and targets a wave of upcoming biologics loss-of-exclusivity opportunities.
NRx says the FDA has identified no bioequivalence deficiencies in its Ketafree ANDA, clearing a key hurdle ahead of a potential mid-2026 decision as the firm pursues parallel generic and innovative ketamine strategies.
Polpharma has opened an India office to work more closely with API suppliers, improve oversight and strengthen supply chain resilience, marking an early strategic move under new CEO Sebastian Szymanek.